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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000446-34 | EudraCT Number |
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| Name | Class |
|---|---|
| Syneos Health | OTHER |
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This is a 28-day clinical trial studying the safety of the house dust mite tablet in adolescents with allergic rhinitis/rhinoconjunctivitis.
The purpose of this trial is to collect additional safety information about a tablet used to treat house dust mite allergies, when used to treat adolescents who have these allergies.
The trial medication used is already approved to treat allergic rhinitis caused by house dust mite in adults and adolescents (12-17 years old) in several countries.
This trial is a 28-day, single-arm open-label phase III trial to evaluate safety of the house dust mite SLIT-tablet in adolescents (12-17 years of age) with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma. Approximately 250 adolescents will be enrolled in the trial and will receive the house dust mite SLIT tablet. The trial is conducted in several European countries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDM SLIT Tablet | Experimental | House dust mite (HDM) Sublingual allergy immunotherapy tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDM SLIT-tablet | Biological | Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) | At least one TEAE | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
| Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) | At least one TEAE | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
| Number of Treatment-emergent Adverse Events (TEAEs) | At least one TEAE | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE) | At least one solicited TEAE | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
| Proportion of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE) |
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Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Horn, MD | HNO Praxis am Neckar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alergologicka ambulance | Čáslav | 28601 | Czechia | |||
| Alergopraktik s.r.o. |
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| ID | Title | Description |
|---|---|---|
| FG000 | HDM SLIT Tablet | House dust mite (HDM) Sublingual allergy immunotherapy tablet HDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 8, 2020 |
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single-armed
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Non applicable
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At least one solicited TEAE |
| From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
| Number of Solicited Treatment-emergent Adverse Events (TEAEs) | At least one solicited TEAE | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
| Number of Subjects With at Least One IMP-related Adverse Event (AE) | At least one IMP-related AE | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
| Proportion of Subjects With at Least One IMP-related Adverse Event (AE) | At least one IMP-related AE | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
| Number of IMP-related Adverse Events (AEs) | At least one IMP-related AE | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
| Number of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) | At least one treatment-emergent SAE | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
| Proportion of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) | At least one treatment-emergent SAE | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
| Number of Treatment-emergent Serious Adverse Events (SAEs) | At least one treatment-emergent SAE | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
| Jablonec nad Nisou |
| 46601 |
| Czechia |
| Allergology Jihlava | Jihlava | 58601 | Czechia |
| Oblastni nemocnice Kolin, a.s. Detske oddeleni. Alergologicka a | Kolín | Czechia |
| Alergologicka ordinace | Kutná Hora | 28401 | Czechia |
| Alergomyšl s.r.o. | Litomyšl | 57014 | Czechia |
| Alergologie SKOPKOVA s.r.o. | Ostrava | 70900 | Czechia |
| KASMED s.r.o. | Tábor | 39002 | Czechia |
| HNO Praxis am Neckar | Heidelberg | Baden-Wrttemberg | 69120 | Germany |
| Praxis Dres. med. Florian Heimlich und Angelika Witzel-Heimlich | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| Praxis Dr. Decot | Dreieich | Hesse | 63303 | Germany |
| Kinderarztpraxis BramscheDr. Thomas Adelt | Bramsche | Lower Saxony | 49565 | Germany |
| HNO-Praxis Dr. med. Udo Schaefer | Dresden | Saxony | 01067 | Germany |
| Facharzt fr HNO und Allergologie | Dresden | Saxony | 013999 | Germany |
| HNO-Genossenschaft Sachsen-Anhalt E.G. | Wolmirstedt | Saxony-Anhalt | 39326 | Germany |
| Ambulancia klinickej imunologie a alergologie | Banská Bystrica | 97405 | Slovakia |
| ALIAN s.r.o. | Bardejov | 08501 | Slovakia |
| Jocia s.r.o. | Bratislava | 82108 | Slovakia |
| AlergoImuno centrum s.r.o. - Ambulancia alergologi | Kežmarok | 06001 | Slovakia |
| ALERGO H2B s.r.o. Ambulancia klinickej imunológie a alergológie | Komárno | 94501 | Slovakia |
| Alersa | Košice | 04022 | Slovakia |
| Ambulancie klinickej imunologie a alergologie Univerzitna nemocnica Martin | Martin | 03659 | Slovakia |
| NZZ Imunologicka ambulancia | Poprad | 05801 | Slovakia |
| Alergo immunological center prešov | Prešov | 08001 | Slovakia |
| Diagnosticke centrum - Ambulancia klinickej imunologie a alergologie, Zoll-Med, s.r.o. | Rimavská Sobota | 901981 | Slovakia |
| Ambulancia klinickej imunologie a alergologie, NZZ Ambulancia klinickej imunologie | Šurany | 94201 | Slovakia |
| Medimun s.r.o. | Trnava | 91701 | Slovakia |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | HDM SLIT Tablet | House dust mite (HDM) Sublingual allergy immunotherapy tablet HDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
| |||||||||||||||||||||||
| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
| ||||||||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||||||||||
| Smoking history | Count of Participants | Participants |
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| Regularly exposed to tobacco smoke | Count of Participants | Participants |
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| Baseline sensitisations | Count of Participants | Participants |
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| Duration of HDM allergic rhinitis/rhinoconjunctivitis | Mean | Standard Deviation | years |
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| Asthma status | Count of Participants | Participants |
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| Inhaled corticosteroids | Count of Participants | Participants |
| |||||||||||||||||||||||
| Duration of asthma | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| FEV1 (percentage predicted) | Mean | Standard Deviation | percentage predicted FEV1 |
| ||||||||||||||||||||||
| FEV1 (L) | Mean | Standard Deviation | liters |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) | At least one TEAE | Posted | Number | subjects | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
|
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| |||||||||||||||||||||||||||
| Primary | Proportion of Subjects With at Least One Treatment-emergent Adverse Event (TEAE) | At least one TEAE | Posted | Number | 90% Confidence Interval | percent | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
|
| |||||||||||||||||||||||||||
| Primary | Number of Treatment-emergent Adverse Events (TEAEs) | At least one TEAE | Posted | Number | events | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE) | At least one solicited TEAE | Posted | Number | subjects | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
|
| ||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With at Least One Solicited Treatment-emergent Adverse Event (TEAE) | At least one solicited TEAE | Posted | Number | 90% Confidence Interval | percent | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Solicited Treatment-emergent Adverse Events (TEAEs) | At least one solicited TEAE | Posted | Number | events | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Subjects With at Least One IMP-related Adverse Event (AE) | At least one IMP-related AE | Posted | Number | subjects | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
|
| ||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With at Least One IMP-related Adverse Event (AE) | At least one IMP-related AE | Posted | Number | 80% Confidence Interval | percent | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
|
| |||||||||||||||||||||||||||
| Secondary | Number of IMP-related Adverse Events (AEs) | At least one IMP-related AE | Posted | Number | events | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) | At least one treatment-emergent SAE | Posted | Number | subjects | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
|
| ||||||||||||||||||||||||||||
| Secondary | Proportion of Subjects With At Least One Treatment-emergent Serious Adverse Event (SAE) | At least one treatment-emergent SAE | Posted | Number | 90% Confidence Interval | percent | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Treatment-emergent Serious Adverse Events (SAEs) | At least one treatment-emergent SAE | Posted | Number | events | From time of first IMP administration and no later than 7 days after last IMP administration, approximately 35 days. |
|
|
AEs were collected from consent to 7 days after end-of-trial or discontinuation (from first IMP intake to 7 days after end-of-trial or discontinuation, up to 35 days).
An AE is any untoward medical occurrence in a clinical trial subject, and which does not necessarily have a causal relationship with the administered IMP.
An AE can therefore be any unfavourable and unintended sign (including e.g. a medication error), symptom, or disease, whether considered related to the IMP.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HDM SLIT Tablet | House dust mite (HDM) Sublingual allergy immunotherapy tablet HDM SLIT-tablet: Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day) | 0 | 253 | 0 | 253 | 223 | 253 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pharyngeal paraesthesia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Pharyngeal swelling | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Ear pruritus | Ear and labyrinth disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Enlarged uvula | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Glossodynia | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Lip oedema | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Lip swelling | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Mouth swelling | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Oedema mouth | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Oral pain | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Oral pruritus | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Swollen tongue | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Tongue eruption | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Tongue ulceration | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Hal Mollerup, Senior Director | ALK-Abelló A/S | +45 45747576 | ClinicalTrials@alk.net |
| Mar 14, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| Unknown or Not Reported |
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| Germany |
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| Not applicable (current smokers) |
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